Mounjaro (autoinjector), Mounjaro(tirzepatide)
Mounjaro, Zepbound (tirzepatide) is a protein pharmaceutical. Tirzepatide was first approved as Mounjaro (autoinjector) on 2022-05-13. It is used to treat type 2 diabetes mellitus in the USA. It has been approved in Europe to treat type 2 diabetes mellitus. It is known to target glucagon-like peptide 1 receptor and gastric inhibitory polypeptide receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Mounjaro, Zepbound
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tirzepatide
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mounjaro | New Drug Application | 2026-01-07 |
| mounjaro mounjaro | New Drug Application | 2026-01-21 |
| zepbound | New Drug Application | 2026-01-07 |
| zepbound zepbound | New Drug Application | 2026-02-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| type 2 diabetes mellitus | EFO_0001360 | D003924 | E11 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TIRZEPATIDE, MOUNJARO, ELI LILLY AND CO | |||
| 2027-05-13 | NCE | ||
TIRZEPATIDE, MOUNJARO (AUTOINJECTOR), ELI LILLY AND CO | |||
| 2027-05-13 | NCE | ||
TIRZEPATIDE, ZEPBOUND, ELI LILLY AND CO | |||
| 2027-05-13 | NCE | ||
| 2026-11-08 | NP | ||
HCPCS
No data
Clinical
Clinical Trials
225 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | 19 | 37 | 26 | 23 | 29 | 129 |
| Overweight | D050177 | — | E66.3 | 9 | 18 | 16 | 8 | 16 | 65 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 10 | 10 | 17 | 9 | 13 | 57 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 7 | 6 | 9 | 4 | 1 | 26 |
| Weight loss | D015431 | — | — | 1 | 4 | 3 | 4 | 6 | 17 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 3 | 4 | 1 | — | 8 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | 2 | 3 | 1 | — | 7 |
| Body weight | D001835 | EFO_0004338 | — | 1 | 2 | — | 1 | 2 | 6 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | 2 | 4 | 6 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | 2 | 2 | 1 | 5 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glucose metabolism disorders | D044882 | — | — | — | 2 | 3 | — | — | 5 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | 2 | 3 | — | — | 5 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | — | 4 | 5 |
| Weight gain | D015430 | — | — | — | — | 1 | — | 2 | 3 |
| Nutrition disorders | D009748 | EFO_0001069 | — | — | 1 | 1 | — | — | 2 |
| Motor activity | D009043 | EFO_0003940 | — | — | — | 2 | — | — | 2 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | 1 | 1 | — | — | 2 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | — | 1 | — | — | 1 |
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | — | — | 1 | — | — | 1 |
| Apnea | D001049 | — | R06.81 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 2 | 3 | — | — | 1 | 6 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 5 | — | — | — | 5 |
| Endometrial hyperplasia | D004714 | — | N85.0 | — | 3 | — | — | 1 | 4 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | — | — | 2 | 3 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 1 | — | — | 1 | 2 |
| Overnutrition | D044343 | — | — | — | 2 | — | — | — | 2 |
| Hyperplasia | D006965 | EFO_0000536 | — | — | 2 | — | — | — | 2 |
| Body-weight trajectory | D000077962 | — | — | — | 1 | — | — | 1 | 2 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 1 | — | — | — | 2 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 10 | — | — | — | — | 10 |
| Hypoglycemia | D007003 | — | E16.2 | 1 | — | — | — | — | 1 |
| Liver failure | D017093 | — | K72.9 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Colorectal neoplasms | D015179 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart disease risk factors | D000082742 | — | — | — | — | — | — | 2 | 2 |
| Dyslipidemias | D050171 | — | — | — | — | — | — | 1 | 1 |
| Hidradenitis suppurativa | D017497 | — | L73.2 | — | — | — | — | 1 | 1 |
| Hidradenitis | D016575 | — | — | — | — | — | — | 1 | 1 |
| Body weight changes | D001836 | — | — | — | — | — | — | 1 | 1 |
| Ablation techniques | D055011 | — | — | — | — | — | — | 1 | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | — | 1 | 1 |
| Feeding and eating disorders | D001068 | — | F50 | — | — | — | — | 1 | 1 |
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tirzepatide |
| INN | tirzepatide |
| Description | Tirzepatide, sold under the brand name Mounjaro among others, is an antidiabetic medication used for the treatment of type 2 diabetes and for weight loss. Tirzepatide is administered via subcutaneous injections (under the skin).
|
| Classification | Protein |
| Drug class | peptides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 2023788-19-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297839 |
| ChEBI ID | — |
| PubChem CID | 156588324 |
| DrugBank | DB15171 |
| UNII ID | OYN3CCI6QE (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Variants
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Financial
Estimated US medical usage
No data
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Mounjaro, Mounjaro mounjaro, Zepbound, Zepbound zepbound
Adverse Events
Top Adverse Reactions
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101,329 adverse events reported
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